Friday, May 14, 2021

Fact Check

Why some gas stations are advertising $9.99 unleaded

If Your Time is shortGas stations will put $9.99 on their signs to indicate that they’re out of gas, not that they’re selling it...

Tucker Carlson Misrepresents Vaccine Safety Reporting Data

SciCheck Digest The Vaccine Adverse Event Reporting System accepts any reports of adverse side effects following vaccination to help regulators detect potential problems. Anyone can submit...

No, this isn’t a real Exxon gas station sign

If Your Time is shortThis image was fabricated online.See the sources for this fact-checkGasoline shortages are affecting some gas stations around the country and...

Magnet Videos Refuel Bogus Claim of Vaccine Microchips

SciCheck Digest The ingredients in the COVID-19 vaccines authorized for use in the U.S. are publicly available. Yet a false claim that the vaccines contain...

Misinformation surges amid India’s COVID-19 calamity

NEW DELHI (AP) — The man in the WhatsApp video says he has seen it work himself: A few drops of lemon juice in...

No, this isn’t a photo of South Carolinians who filled plastic bags with gas

If Your Time is shortA photo of plastic bags filled with gas is from a 2019 arrest in Mexico, not the United States in...

US Politics
Latest

Stefanik voted in as House GOP’s new No. 3 leader

After the vote concluded, Stefanik walked to speak to reporters with House Minority Leader Kevin McCarthy and other members of the leadership team by...

Jenner’s claim she didn’t vote at odds with LA county record

SACRAMENTO, Calif. (AP) — Caitlyn Jenner wants to be governor of California but she took a pass on voting on some of the state’s...

Michigan Republican wants to register fact-checkers

LANSING, Mich. (AP) — A Michigan Republican known for challenging the results of the 2020 presidential election has turned his attention to those who...

Cicilline seeks to censure Republicans who dismiss Jan. 6 insurrection

He specifically pointed to recent comments made by GOP Reps. Andrew Clyde (Ga.), Jody Hice (Ga.) and Paul Gosar (Ariz.). The resolution may face...

New York approves vaccinations of kids aged 12 to 15

ALBANY, N.Y. (AP) — Children between the ages of 12 and 15 can get vaccinated in New York effective immediately, Gov. Andrew Cuomo said...

LGBTQ

Ellen lashes out at “misogynistic” & “coordinated” attacks. She’s finished being kind. / LGBTQ Nation

Ellen DeGeneres at the 41st Annual People's Choice Awards held at the Nokia L.A. Live Theatre in Los Angeles on January 7, 2015.Photo: ShutterstockEllen...

Mother exorcises “foul spirits” from gay teen’s room in viral video / LGBTQ Nation

The gay teen's mom banishing Satan from her roomPhoto: Screenshot/TikTokA video of a Christian mother exorcising her gay daughter’s room has gone viral. “If you’re...

Is climate change an LGBTQ issue? Let’s find out on this week’s podcast. / LGBTQ Nation

The latest episode of the LGBTQ Nation podcast has arrived and we’re figuring out whether climate change is an LGBTQ issue. On this week’s episode, host...

Tech

EU to discuss US vaccine patent plan at Friday summit

BRUSSELS (AP) — European Union leaders said Thursday that in the wake of the U.S. backing patent waivers for COVID-19 vaccine technology, the 27-nation...

Streaming revenue boosts ViacomCBS Q1 results

ViacomCBS’s first-quarter net income beat expectations on strong streaming revenue during a quarter when the company aired the Super Bowl and introduced its rebranded...

In a first, FDA cites violation of clinical trials reporting law

Must read

Internal emails reveal WHO knew of sex abuse claims in Congo

BENI, Congo (AP) — When Shekinah was working as a nurse’s aide in northeastern Congo in January 2019, she said, a World Health Organization...

Why some gas stations are advertising $9.99 unleaded

If Your Time is shortGas stations will put $9.99 on their signs to indicate that they’re out of gas, not that they’re selling it...

Tucker Carlson Misrepresents Vaccine Safety Reporting Data

SciCheck Digest The Vaccine Adverse Event Reporting System accepts any reports of adverse side effects following vaccination to help regulators detect potential problems. Anyone can submit...

Stefanik voted in as House GOP’s new No. 3 leader

After the vote concluded, Stefanik walked to speak to reporters with House Minority Leader Kevin McCarthy and other members of the leadership team by...

The Food and Drug Administration has for the first time warned a sponsor of a clinical trial that it had failed to follow a law requiring the posting online of the data from the study.

Sarah Silbiger/Getty Images

In an unprecedented enforcement action, the Food and Drug Administration (FDA) yesterday informed a clinical trial sponsor that it had violated the law requiring that results from human studies of medical treatments and devices be posted to the federal repository ClinicalTrials.gov. The action was leveled against the Cambridge, Massachusetts–based drug company Acceleron Pharma for its failure to provide data from a completed trial of its experimental drug to treat kidney cancer.

Such data must generally be deposited within 1 year of a trial’s end, but Acceleron’s results are nearly 3 years past due. Acting FDA Commissioner Janet Woodcock said in a written statement about the 27 April notification that the agency takes its enforcement role “very seriously … for the benefit of clinical trial participants and public health.”

Acceleron ceased the drug’s development in 2017, following the trial’s disappointing results, according to a company spokesperson. The results were published in a scientific journal in 2019 but not everyone can access such publications so the law mandates the basic results be added to the public website. FDA gave the company 30 more days to post the results or face financial penalties; the spokesperson says it will comply.

Since 2007, the U.S. government has required companies, universities, federal agencies, and nonprofits that sponsor clinical trials to report their results, whether positive, negative, or inconclusive, so that doctors, patients, and researchers can learn about the safety and efficacy of new drugs or devices. Congress created the reporting law after pharma companies suppressed data revealing lucrative drugs to be unsafe or ineffective.

In 2017, FDA and the National Institutes of Health, which oversees the law for the researchers it funds, released a “final rule” to clarify the requirements and the penalties for ignoring them. When NIH Director Francis Collins announced that rule, he warned trial sponsors that if they violate the reporting law they would be listed on a ClinicalTrials.gov “wall of shame”—Acceleron is now its first entry. Since the rule took full effect in January 2018, some large universities and companies have improved their reporting performance, but for thousands of trials, sponsors still ignore the law, investigations in Science and elsewhere have found.

FDA can collect more than $10,000 per day in penalties when companies break the law; the total penalties could have amounted to more than $19 billion since 2018, according to a tracking site at the University of Oxford. FDA has yet to collect a single dollar. NIH can also withhold violators’ grant funds but has never done so. Instead, both agencies have encouraged voluntary compliance—until now.

As vice president, Joe Biden pledged in 2016 to enforce the clinical trials law after learning it was being ignored. Wednesday’s action is the first sign that his administration would reverse years of passive acceptance that the law is widely ignored.

It remains to be seen whether FDA will crack down on the many other trials with overdue results. The agency did not immediately respond to a request for information on its future enforcement plans.

Deborah Zarin, a physician at the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University who headed ClinicalTrials.gov between 2005 and 2018, applauds FDA’s action. But she says it was unclear why the agency chose Acceleron out of thousands of other violators. “It will be important for FDA and NIH to follow this up with a program of systematic monitoring and enforcement,” Zarin says. “Human nature is such that without a clear risk of sanctions for noncompliance, institutions and investigators are simply not going to report results when it is inconvenient or seems contrary to their interests.”

Source link

- Advertisement -

More articles

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Latest article

Internal emails reveal WHO knew of sex abuse claims in Congo

BENI, Congo (AP) — When Shekinah was working as a nurse’s aide in northeastern Congo in January 2019, she said, a World Health Organization...

Why some gas stations are advertising $9.99 unleaded

If Your Time is shortGas stations will put $9.99 on their signs to indicate that they’re out of gas, not that they’re selling it...

Tucker Carlson Misrepresents Vaccine Safety Reporting Data

SciCheck Digest The Vaccine Adverse Event Reporting System accepts any reports of adverse side effects following vaccination to help regulators detect potential problems. Anyone can submit...

Stefanik voted in as House GOP’s new No. 3 leader

After the vote concluded, Stefanik walked to speak to reporters with House Minority Leader Kevin McCarthy and other members of the leadership team by...

EU to discuss US vaccine patent plan at Friday summit

BRUSSELS (AP) — European Union leaders said Thursday that in the wake of the U.S. backing patent waivers for COVID-19 vaccine technology, the 27-nation...